Ireland's NCCP Issues New Guidance on Biosimilars in Oncology

Ireland’s National Cancer Control Programme (NCCP) has issued new guidance on the use of biosimilar medicines in the treatment of cancer.

The guidance includes recommendations on 4 areas of concern with biosimilar products:

• Usage. The use of a biosimilar should be in line with licensed indications, and biosimilars should only be used after clinicians have consulted with their patients and with other healthcare professionals (including nurses and pharmacists). Implementation of biosimilar policies should follow a staged approach and should include engagement with all relevant stakeholders, including patients.
• Prescribing. Treatments for which biosimilars are available should be prescribed using the brand name (for example, a clinician would prescribe “MabThera” or “Truxima,” not simply “rituximab”) in order to avoid any confusion about which drug a patient will receive and to ensure correct reporting of adverse events. Hospitals whose policies have adequate safeguards with respect to product dispensing may be exempt from the brand-name prescribing guideline.
• Switching. New patients can be considered for treatment with a biosimilar, but clinicians should discuss the decision with the patient and use all available evidence to guide decision-making about the individual’s needs. Furthermore, all existing patients who are receiving reference products can be considered for switching to biosimilars (after appropriate patient-clinician consultation). However, frequent switching between reference products and biosimilars is discouraged.
• Patient Information. Patients should be supplied with, and encouraged to read, educational leaflets that will help them to become familiar with their treatments. Ireland’s Health Products Regulatory Agency is currently developing patient-focused general information about biosimilars for distribution on its website.

The NCCP’s guidance also indicates that, in Ireland, substitution of biosimilars by pharmacists is not currently provided for under the law. Therefore, any change between a reference product and a biosimilar must involve the prescribing physician.

The NCCP says that it welcomes the introduction of biosimilars into the Irish healthcare marketplace, and that biosimilars represent a way to “obtain sustainability and [maximize] the funding for new medicines to be made available for patient treatment.”

Ireland has already undertaken work to address the cost of biologic medications in order to make cancer treatment more sustainable; its 2016 Framework Agreement on the Supply and Pricing of Medicines, an agreement between the pharmaceutical industry and the government, held that the price the government’s health system pays for a biologic treatment that loses patent protection after August 1, 2016 must drop to 80% of its July 31, 2016 price. The government also requires that manufacturers make available an additional rebate of 12.5% on such reference biologics.

Ireland’s Minister for Health has also recently published a consultation paper on the nation’s approach to biosimilar treatments in order to encourage wider use of cost-saving drugs. Despite the fact that 11 biosimilars are currently reimbursable by the state’s health system, Ireland has one of the lowest biosimilar adoption levels in Europe. The government will receive public comments on the paper, which calls for the exploration of a variety of potential policies to encourage biosimilar uptake, until September 22, 2017.